FDA recall Z-0100-2022

Smiths Medical ASD Inc. · Class II · device

Product

smiths medical medex CBSS-5ML Antishunt set, (172/15cm), Model Number DPSHC0091

Reason for recall

Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets.

Distribution

Austria, France, Germany, Great Britain, and Saudi Arabia

Key facts

Status: Terminated
Initiation date: 2020-03-10
Report date: 2021-10-20
Termination date: 2023-09-22
Voluntary/Mandated: Voluntary: Firm initiated
Location: Minneapolis, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0100-2022